FAST TRACK: IND Enabling Studies for Oral Cancer

DESCRIPTION provided by applicant According to the Oral Cancer OC Foundation oral and pharyngeal cancer will cause deaths this year in the US killing roughly one person per hour Currently cisplatin CIS is at the forefront of platinum based chemotherapeutics for treating OC However its efficacy is often hindered by its significant systemic toxicity as a resut of traditional bolus systemic intravenous IV doses In this proposal entitled andquot Fast track IND enabling studies for Oral Cancerandquot the critical path is performing the studies required by the FDA to successfully achieve the the IND status for safety trials Privoandapos s specific aims for phase I focs on conducting in vivo studies to further fine tune the dosing of Privoandapos s lead optimized formulation for its ChemoThin Wafer CTW c For the Phase II of this project the focus is on conducting IND enabling studies to prepare Privo for human safety trial Privoandapos s CTW c contains anticancer chemotherapy agent cisplatin which is the gold standard chemotherapy drug for oral cancer It is designed and optimized for local and topical treatment of OC thus replacing injection increasing the drugandapos s efficacy and significantly reducing its systemic toxicity The CTW c platform contains FDA approved chemotherapy drugs and generally recognized as safe GRAS materials It utilizes nano encapsulation techniques to incorporate drugs into NPs with a controlled release design that releases chemo drugs at fully tunable and pre determined rates The year survival of patients with OC has not significantly improved over the past several decades Moreover the survival rate for early detection is significantly higher than later stages vs Therefore for patients with pre malignant to non metastasized malignant OC this reformulated nano encapsulated CTW c delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer The ultimate objective of Privo Technologies is to develop and commercialize effective safe and convenient chemotherapy treatments accessible to many patients PUBLIC HEALTH RELEVANCE SBIR R R application entitled andquot Fast Track IND enabling studies for Oral Cancerandquot Project Narrative Privoandapos s nano engineered topical ChemoThin Wafer CTW c treatment has the potential to deliver a very high concentration of the chemotherapy drug while significantly limiting its toxicity It is mainly intended for topical and local treatmet of pre malignant and malignant oral cancer tumors that have not yet metastasized to distant organs This CTW c may also provide a necessary alternative to patients who are unable to receive conventional chemotherapy due to suffering from chronic diseases such as compromised kidney